Medical devices have evolved greatly over the last 75 years. From robotic surgical systems to telemedicine, AR/VR, and 3D printing, technological innovations are constantly revolutionizing the healthcare industry. Nowadays, medical devices have become indispensable tools in modern healthcare, and by extension, our daily lives. Due to the growing medical device market and increasing software complexity, regulations governing risk management in medical devices have recently become more stringent. The most important standard for risk management in medical device development is ISO 14971:2019. Read on to learn more about it and how it affects your organization!
Risk management in medical device development
Medical devices play a crucial role in modern healthcare. EU MDR defines medical devices as “any instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use, software, material or another similar or related article, intended by the manufacturer to be used, alone or in combination” for certain medical purposes.
Medical devices range from simple tools like band-aids and tongue depressors all the way to nebulizers, artificial hips, and MRI body scanners. They provide innovative solutions for:
The diagnosis, prevention, monitoring, and treatment of disease
- The diagnosis, monitoring, and treatment of injuries
- The modification, support, or replacement of a body part or physiological process
- Supporting or sustaining life
- Birth control methods
- In-vitro examinations
- Device disinfection
- And more
Today there are approximately 2 million types of different medical devices available on the global market, which makes risk management in medical device development a very serious business. Since the safety of patients, healthcare workers, and the environment is at stake, medical device manufacturers have to ensure that their products work as intended and that they will not cause harm to anyone.
Without demonstrating their devices' reliability, high quality, and patient safety characteristics, medical device manufacturers will not be able to go to market with their products. The safety-critical nature of medical devices and the pressure to comply with international standards for market access is why manufacturers must use a rigorous framework for risk management, which is where ISO 14971:2019 comes in.
What is ISO 14971:2019?
ISO 14971:2019 is the industry’s state-of-the-art standard for risk management in medical devices. The third edition of this standard was issued in December 2019 and has since been recognized as the consensus standard by the FDA which designated a transition period from its 2007 edition ending in December 2022.
It is internationally recognized by:
- The U.S. Food and Drug Administration (FDA)
- Australia’s Therapeutic Goods Association (TGA)
- Japan’s Ministry of Health, Labor, and Welfare
And while it has not officially been harmonized with the EU MDR yet, the EU MDR’s risk management requirements essentially mirror the contents of ISO 14971.
ISO 14971 typically forms part of a medical Quality Management System, which ensures that the end product is safe for human use, is of high quality, and is demonstrably compliant with industry regulations. The document details a comprehensive framework for managing the risks that are associated with medical devices. This process, in general, is used to:
- Identify all types of hazards that may potentially occur during the use of the device
- Estimate risks by analyzing their characteristics
- Develop and implement risk management measures to prevent those risks from causing harm
- Monitor and evaluate the effectiveness of such measures
To whom does ISO 14971:2019 apply (and is it mandatory)?
ISO 14971 applies to manufacturers of medical devices all over the world. The standard outlines a thorough process for managing risks in medical devices, including both software as a medical device and in vitro diagnostic medical devices.
ISO 14971 emphasizes the importance of implementing risk management at every stage of the product cycle, rather than addressing it later on in the process as a checkbox activity. This means that the requirements described in the document must be fulfilled at every phase of the product life cycle.
Compliance with ISO 14971 is mandatory, with notified bodies auditing medical device developers’ technical files for all their marketed devices on a regular basis – ISO 14971 is a fundamental standard that plays a role in those audits. Demonstrated adherence to the requirements of ISO 14971 also acts as a vote of confidence for suppliers, distributors, and clients who prefer to work with manufacturers who are ISO 14971-compliant.
How are ISO 14971:2019 and ISO 13485:2016 related?
ISO 13485 – Quality management systems is another very important standard for manufacturers and suppliers in the business of developing medical devices.
This document, whose latest edition was published in 2016, provides requirements on how medical device manufacturers should set up and use Quality Management Systems (QMS). The idea behind it is to standardize medical device development processes.
ISO 13485 is specific to the medical device industry. As a result, it works hand in hand with ISO 14971 to create a QMS which addresses risk throughout the entire product life cycle.
ISO 14971:2019 risk management process
ISO 14971 outlines specific processes and best practices for implementing risk management throughout the entire lifecycle of a medical device, all the way from conception to retirement.
Here are some of the key steps highlighted in the document:
- Establish a risk management plan
This plan provides a roadmap for the risk management process overarching the device’s development lifecycle. For every stage of the lifecycle, you’ll plan risk management activities and the responsibilities of different staff members and management.
- Risk assessment
Risks are identified, described, documented, and their scope as well as the definition of safety are outlined. Based on risk analysis that takes into account the intended use of the device, risks are evaluated and documented.
- Risk evaluation
Risks are assessed in order to determine which are acceptable and which need controls in place. The boundaries of intended use are set, clearly defining what’s considered reasonably foreseeable use or misuse of the product, which will affect the necessary risk control measures.
- Risk Control
Risk control measures are developed and implemented to get unacceptable risks back under control. In essence, the goal of this step is to eliminate or reduce risks to an acceptable level. The ideal scenario is that you’ll create an inherently safe design. In cases where that’s not possible, you’ll implement protective measures to reduce the probability that a hazardous situation occurs, or if it does, the severity of the harm caused. If even that is impossible, you’ll provide safety information to the users of the device. Any residual risk will also need to be evaluated.
- Management review
Before the product is shipped, management needs to review the whole process and risk management file to ensure that the risk management plan was adequately executed and implemented to ensure that the product is ISO 14971-compliant.
- Production and post-production
All information, risks, and risk controls are reviewed to make sure that no new measures are needed and everything is in place.